Section 3400. General technical requirements for facilities using therapeutic radiation machines

A. Protection surveys.

1. The registrant shall ensure that radiation protection surveys of all new facilities and existing facilities not previously surveyed are performed with an operable radiation measurement survey instrument calibrated in accordance with 12VAC5-481-3440. The radiation protection survey shall be performed by, or under the direction of, a qualified medical physicist or a qualified inspector and shall verify that, with the therapeutic radiation machine in a "BEAM-ON" condition, with the largest clinically available treatment field, and with a scattering phantom in the useful beam of radiation:

a. Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in 12VAC5-481-640; and

b. Radiation levels in unrestricted areas do not exceed the limits specified in 12VAC5-481-720.

2. In addition to the requirements of subdivision 1 of this subsection, a radiation protection survey shall also be performed prior to any subsequent medical use and:

a. After making any change in the treatment room shielding;

b. After making any change in the location of the therapeutic radiation machine within the treatment room;

c. After relocating the therapeutic radiation machine; or

d. Before using the therapeutic radiation machine in a manner that could result in increased radiation levels in areas outside the external beam radiation therapy treatment room.

3. The survey record shall indicate all instances where the facility, in the opinion of the qualified medical physicist or a qualified inspector, is in violation of applicable regulations. The survey record shall also include the date of the measurements, the reason the survey is required, the manufacturer's name, the model number and serial number of the therapeutic radiation machine, the instruments used to measure radiation levels, a plan of the areas surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in microsieverts or millirems per hour, the calculated maximum level of radiation over a period of one week for each restricted and unrestricted area, and the signature of the individual responsible for conducting the survey;

4. If the results of the surveys required by subdivision 1 or 2 of this subsection indicate any radiation levels in excess of the respective limit specified in subdivision 1 of this subsection, the registrant shall lock the control in the "OFF" position and not use the unit:

a. Except as may be necessary to repair, replace, or test the therapeutic radiation machine, the therapeutic radiation machine shielding, or the treatment room shielding; or

b. Until the registrant has received a specific exemption from the agency.

B. Modification of radiation therapy unit or room before beginning a treatment program. If the survey required by subsection A of this section indicates that an individual in an unrestricted area may be exposed to levels of radiation greater than those permitted by 12VAC5-481-720, before beginning the treatment program the registrant shall:

1. Either equip the unit with beam direction interlocks or add additional radiation shielding to ensure compliance with 12VAC5-481-720;

2. Perform the survey required by subsection A of this section again; and

3. Include in the report required by subsection D of this section the results of the initial survey, a description of the modification made to comply with subdivision 1 of this subsection, and the results of the second survey; or

4. Request and receive a registration amendment under 12VAC5-481-720 that authorizes radiation levels in unrestricted areas greater than those permitted by 12VAC5-481-720.

C. Dosimetry equipment.

1. The registrant shall have a calibrated dosimetry system available for use. The system shall have been calibrated by the National Institute for Standards and Technology (NIST) or by an American Association of Physicists in Medicine (AAPM) Accredited Dosimetry Calibration Laboratory (ADCL). The calibration shall have been performed within the previous 24 months and after any servicing that may have affected system calibration. An independent survey shall be conducted by a qualified inspector or qualified medical physicist other than the person performing the original survey prior to the equipment being used except as described in subsection A of this section:

a. For beams with energies greater than one MV (1 MeV), the dosimetry system shall have been calibrated for Cobalt-60;

b. For beams with energies equal to or less than one MV (1 MeV), the dosimetry system shall have been calibrated at an energy (energy range) appropriate for the radiation being measured;

2. The registrant shall have available for use a dosimetry system for quality assurance check measurements. To meet this requirement, the system may be compared with a system that has been calibrated in accordance with subdivision 1 of this subsection. This comparison shall have been performed within the previous 12 months and after each servicing that may have affected system calibration. The quality assurance check system may be the same system used to meet the requirement in subdivision 1 of this subsection;

3. The registrant shall maintain a record of each dosimetry system calibration, intercomparison, and comparison for the duration of the license or registration. For each calibration, intercomparison, or comparison, the record shall include: the date; the model numbers and serial numbers of the instruments that were calibrated, inter-compared, or compared as required by subdivisions 1 and 2 of this subsection; the correction factors that were determined; the names of the individuals who performed the calibration, intercomparison, or comparison; and evidence that the intercomparison was performed by, or under the direct supervision and in the physical presence of, a qualified medical physicist.

D. Reports of external beam radiation therapy surveys and measurements. The registrant for any therapeutic radiation machine subject to 12VAC5-481-3420 or 12VAC5-481-3430 shall furnish a copy of the records required in subsections A and B of this section to the agency within 30 days following completion of the action that initiated the record requirement.

Historical Notes

Derived from Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 17, eff. June 5, 2016.

Statutory Authority

§§ 32.1-12 and 32.1-229 of the Code of Virginia.